[17 April 2013]
Products Affected - Description
Azathioprine injection, lyophilized powder, Bedford
100 mg vial (NDC 55390-0600-20)
Reason for the Shortage
- Ben Venue voluntarily entered into a consent decree with FDA in late-January, 2013. The terms allow Ben Venue to continue to manufacture over 100 medications as long as they are compliant with the decree. FDA will continue to work with Ben Venue to ensure the products are being made with federal current good manufacturing practice requirements. Ben Venue supplies multiple products for Bedford Laboratories, a division of Ben Venue.
- There are no other manufacturers of azathioprine injection.
- The oral presentations are not affected by this shortage.
No presentations are available.
Estimated Resupply Dates
Bedford has azathioprine 100 mg vials on back order and the company will not resume production until capacity permits.
April 17, 2013; March 7, 2013; January 28, 2013; December 17, 2012; October 30, 2012; September 10, 2012; July 12, 2012; June 19, 2012; May 4, 2012; March 26, 2012; February 3, 2012; December 9, 2011; November 21, 2011; October 27, 2011; September 29, 2011; August 3, 2011; July 1, 2011; June 29, 2011; May 20, 2011, University of Utah, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
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